Equinoxe 315-52-63Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862558176), received between Jun 4, 2019 and Aug 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

18 other recalls cover devices cleared under the same FDA submission (K042021, K093430, K113309); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Break; Fracture; Break; Fracture

  AS REPORTED, THE SURGEON WAS DRILLING OVER THE K-WIRE AND THE K-WIRE WAS BENT BUT NO ONE SAW AND THE DRILL SNAPPED WHEN IT WAS BEING DRILLED OF THE BENT PART. FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT AND WERE REMOVED. AFTER THE DRILL BROKE EVERYTHING WAS REMOVED AND CONFIRMED BY X-RAY. NO ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. AFTER EVERYTHING WAS REMOVED WE MOVED ON WITH SURGERY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICE IS NOT RETURNING AS IT WAS A SHARP AND WAS THROWN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213928 ↗
• MalfunctionJun 4, 2019Break

  WHILE DRILLING FOR THE CENTER HOLE THAT WILL ACCOMMODATE THE CAGE OF THE IMPLANT. AS THE SURGEON BEGAN TO DRILL INTO THE BONE IN THE USUAL FASHION, THE 3.2MM CANNULATED DRILL SHATTERED IN THE PATIENT¿S GLENOID. ONCE THE REMAINING PART OF THE DRILL WAS REMOVED FROM THE K-WIRE, THE SURGEON REALIZED THE K-WIRE ALSO BROKE/SNAPPED IN THE PATIENT¿S GLENOID. THE K-WIRE APPEARED TO HAVE BROKEN AT THE LAST THREAD BEFORE THE SMOOTH PART OF THE K-WIRE. THE SURGEON SPENT AN EXTRA 5-10 MINUTES TRYING TO REMOVE A PIECE OF THE SHATTERED DRILL AND WAS ABLE TO REMOVE ONE PIECE OF THREE FROM THE GLENOID. THE OTHER TWO PIECES OF THE 3.2 CANNULATED DRILL AND THE THREADED TIP OF THE BROKEN 3.2 K-WIRE PUSHED THROUGH THE PATIENT¿S GLENOID AND WAS RETAINED IN THE PATIENT. THE SURGEON THEN IMPLANTED THE BASEPLATE AND DRILLED FOR SCREWS AS NORMAL. THE REST OF THE CASE WENT AS PLANNED. POST-OP X-RAYS WERE TAKEN FOLLOWING SURGERY AND CONFIRMED THAT TWO PIECES OF THE DRILL AND THE ONE PIECE OF THE K-WIRE IS RETAINED IN THE GLENOID BONE AND DOES NOT APPEAR TO BE FLOATING, IT IS IN THE BONE. THE PATIENT WAS UNDER ANESTHESIA FOR EXTRA TIME DUE TO THIS EVENT. THE PATIENT LEFT THE OR IN STABLE CONDITION. THE BROKEN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8666490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430, K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Compone
• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Compone
• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece
• Z-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t

…and 3 more.